NCT05277454

Clinical Study of HMPL-653 in Treatment of Advanced Malignant Solid Tumors and TGCT

A Multicenter, Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-653 in Treatment of Patients With Advanced Malignant Solid Tumors and Tenosynovial Giant Cell Tumor

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 113 (estimated)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of HMPL-653 in patients with advanced solid tumors who have failure of standard of care or can not tolerate standard of care or those with TGCT, and to determine the maximum tolerated dose (MTD) and/or the recommended phase II clinical study dose (RP2D) of HMPL-653 in patients with advanced solid tumors.

Conditions

• Advanced Malignant Solid Tumors
• TGCT

Interventions

Type	Name	Description
DRUG	HMPL-653	Dose-escalation Stage: Several dose levels will be evaluated for HMPL-653. The participants will receive oral HMPL-653 single-dose evaluation and oral HMPL-653 QD continuously treatment in a therapeutic cycle of 28 days until reaching the criteria for the end of treatment. Dose-expansion Stage: The participants will receive HMPL-653 treatment （RP2D）until reaching the criteria for the end of treatment.

Timeline

• Start date: 2022-01-18
• Primary completion: 2024-06-28
• Completion: 2025-04-14
• First posted: 2022-03-14
• Last updated: 2022-03-14

Locations

5 sites across 1 country: China